- Device
- TRIDYNE VASCULAR SEALANT; TRIDYNE VS Standard Spray Tips; TRIDYNE VS 6 Extended Spray Tip
- Applicant
- Neomend, Inc.
- PMA number
- P150016
- Supplement
- S009
- Product code
- NBE
- Generic name
- Sealant, polymerizing
- Decision date
- 2018-08-10
- Decision code
- APPR
- Date received
- 2017-11-28
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval to implement changes to the human serum albumin (HSA) filling and polyethylene glycol (PEG) filling processes.